MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA 4K UHD XENON LIGHT SOURCE

Model Number CLV-S400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 11/08/2021

Event Type  Injury  

Event Description

The customer reported to olympus a patient suffered a burn from the subject device at the beginning of a procedure.During set-up for an unspecified laparoscopic case, after the drapes were placed, the surgeon took the light cord and handed it to the circulating rn to connect the light source.The light source was connected and it automatically turned on.While the nurse was connecting the other tubing and continuing with set up, the surgeon was holding the light source while turned on and laid the light cord on the patient's abdomen.It was then noticed there was a 2nd degree burn on the patient's skin.The burn was incorporated into the patient's incision.The customer reported another light source was used however it is unclear why.The procedure was successfully completed.

• Brand Name: VISERA 4K UHD XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12978696
• MDR Text Key: 282092743
• Report Number: 2951238-2021-00450
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170374579
• UDI-Public: 04953170374579
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/12/2021,12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CLV-S400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/12/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AWA03310A, UNKNOWN SERIAL